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临床试验/NCT07705009
NCT07705009已完成不适用

Procedure Time and Patient Comfort of Intraoral Scanning Versus Alginate Impressions Among Dental Students: A Randomized Clinical Trial

Hue University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2025年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
171
试验地点
1
主要终点
Total Chairside Procedure Time

研究概览

简要总结

Dental impressions are used to create a record of a person's teeth and oral structures. Conventional impressions are made using impression material placed in a tray, whereas digital impressions are obtained using an intraoral scanner.

This randomized clinical trial compared conventional alginate impressions with digital intraoral scanning using the TRIOS 3 and Medit i700 scanners among dental students aged 18 to 24 years. Participants were randomly assigned to one of the three impression techniques. Each participant underwent recording of both the upper and lower dental arches using the assigned technique.

The study primarily compared the chairside time required for each technique and the participants' experience immediately after the procedure. Comfort, nausea, breathing, pain, dry-mouth sensation, perceived procedure speed, overall satisfaction, and preference for conventional or digital impressions were also evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Undergraduate dental students at the University of Medicine and Pharmacy, Hue University.
  • Aged 18 to 24 years.
  • Willing to undergo one maxillary and one mandibular dental impression using the assigned technique.
  • Willing and able to complete the study questionnaire.
  • Provided written informed consent.

排除标准

  • Currently undergoing orthodontic treatment.
  • Presence of a systemic disease or acute condition that limited the ability to cooperate or increased the risk of discomfort during impression taking or intraoral scanning, including an acute respiratory disorder or frequent vomiting.
  • Limited mouth opening or an oral and maxillofacial condition that prevented correct impression-tray seating or scanner-tip placement according to the study protocol.
  • A maxillofacial abnormality that markedly affected the procedure or caused significant recording distortion.
  • An excessive gag reflex that prevented completion of the assigned procedure.

结局指标

主要结局

Total Chairside Procedure Time

时间窗: During the assigned impression procedure at the single study visit

Total chairside procedure time was measured in seconds using a digital stopwatch and calculated as the sum of the recorded procedural stages. For the conventional alginate group, the stages included maxillary mixing, maxillary impression taking, mandibular mixing, and mandibular impression taking. For the digital groups, the stages included patient and case information entry, maxillary scanning, and mandibular scanning. Bite-registration time was excluded from the total procedure time because there was no equivalent stage in the conventional alginate workflow.

Patient-Reported Overall Comfort During the Impression Procedure

时间窗: Immediately after completion of the assigned impression procedure

Overall comfort during the assigned impression procedure was assessed immediately after the procedure using a 0-to-100 visual analogue scale. Higher scores indicated greater comfort.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Le Van Nhat Thang

Principal Investigator

Hue University of Medicine and Pharmacy

研究点 (1)

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